The CDASH Model establishes a standard way to collect data across studies. Guidance in this section implements the CDASH Model and provides:
- Basic data collection guidance and best practices.
- Guidance for development, management, and use of case report forms (CRFs) irrespective of the inclusion of collected data in subsequent tabulation datasets.
The TIG supports development of CRFs but does not formally address data collection via other sources. Guidance in this section suggests a format to be presented to those entering collected data using CRFs but does not dictate any data structure or system in which to store the collected data. Although not formally addressed in the TIG, the principles and metadata presented can be applied to eSource (also known as "non-CRF") data, such as vendors' electronic data transfer standards and ePRO data structures, as applicable.
Overview
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